Trial record 1 of 1 for:
NCT00938431
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00938431 |
Recruitment Status :
Completed
First Posted : July 13, 2009
Results First Posted : December 15, 2015
Last Update Posted : March 19, 2019
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Epilepsy |
Intervention |
Drug: Lacosamide |
Enrollment | 47 |
Participant Flow
Recruitment Details | The SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study. |
Pre-assignment Details |
Arm/Group Title | >=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) |
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Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment |
Period Title: Overall Study | |||
Started | 15 | 23 | 9 |
Completed | 9 | 14 | 1 |
Not Completed | 6 | 9 | 8 |
Reason Not Completed | |||
Adverse Event | 5 | 8 | 6 |
Lack of Efficacy | 0 | 1 | 0 |
Did not up titrate to 12 mg kg/day | 1 | 0 | 0 |
Dosing compliance issue | 0 | 0 | 1 |
Reached maximum dose early | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | >=1 Month to <4 Years (Safety Set) | >=4 Years to <12 Years (Safety Set) | >=12 Years to <=17 Years (Safety Set) | Total Title | |
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Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | Subjects were classified as belonging to the age group based on their age at time of enrollment | [Not Specified] | |
Overall Number of Baseline Participants | 15 | 23 | 9 | 47 | |
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The analysis group for Baseline Characteristics is the Safety Set (SS). The SS is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Age (years) | Number Analyzed | 15 participants | 23 participants | 9 participants | 47 participants |
1.58 (1.02) | 7.41 (2.44) | 15.15 (1.50) | 7.03 (5.12) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 23 participants | 9 participants | 47 participants | |
Female |
10 66.7%
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9 39.1%
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5 55.6%
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24 51.1%
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Male |
5 33.3%
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14 60.9%
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4 44.4%
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23 48.9%
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Weight
Mean (Standard Deviation) Unit of measure: Kilograms |
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Number Analyzed | 15 participants | 23 participants | 9 participants | 47 participants | |
9.90 (3.31) | 26.73 (10.20) | 54.10 (10.49) | 26.60 (17.64) | ||
Height
Mean (Standard Deviation) Unit of measure: Centimeters |
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Number Analyzed | 15 participants | 23 participants | 9 participants | 47 participants | |
79.64 (11.22) | 121.81 (14.86) | 158.93 (11.43) | 115.46 (31.23) | ||
BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 15 participants | 23 participants | 9 participants | 47 participants | |
15.27 (2.33) | 17.39 (2.68) | 21.38 (3.12) | 17.48 (3.37) | ||
Racial Group
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 15 participants | 23 participants | 9 participants | 47 participants |
Asian | 1 | 1 | 0 | 2 | |
Black | 0 | 4 | 3 | 7 | |
White | 7 | 18 | 5 | 30 | |
Other/ Mixed | 7 | 0 | 1 | 8 | |
Ethnicity
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 15 participants | 23 participants | 9 participants | 47 participants |
Hispanic or Latino | 11 | 7 | 3 | 21 | |
Not Hispanic or Latino | 4 | 16 | 6 | 26 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Name/Title: | Study Director |
Organization: | UCB |
Phone: | +1877 822 9493 |
Publications of Results:
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00938431 |
Other Study ID Numbers: |
SP0847 2011-001558-27 ( EudraCT Number ) |
First Submitted: | July 2, 2009 |
First Posted: | July 13, 2009 |
Results First Submitted: | June 29, 2015 |
Results First Posted: | December 15, 2015 |
Last Update Posted: | March 19, 2019 |